Small incision lens

ABSTRACT

This patent represents a deformable artificial intraocular lens for implantation into the human eye. The lens is used for implantation after cataract surgery. The lens optic consists of one smooth optical surface. The second optical surface is a series of annular concentric rings. The rings allow the lens to have extremely thin edges, which reduce glare, halos, and distortion. The extremely thin lens optic along with the thin haptic can be rolled, folded, or squeezed to pass through a small incision (&lt;1.5 millimeters) in the cornea or sclera of the human eye. This lens represents a breakthrough in removal of mass from the lens. The ultra thin lens and haptic design allows the lens to move in the eye providing accommodation for the patient. The lens and haptic design reduces the radial forces on the eye to the point where the naturally occurring pressures in the eye move the lens thus providing accommodation. In all current lens designs the haptics apply enough radial force to prevent the natural forces in the eye from moving the lens. The ultra thin lens and haptic design allows the lens to move in the eye providing accommodation for the patient.

This application claims benefit of co-pending U.S. Provisional PatentApplication Serial No. 60/305,811 filed Jul. 17, 2001, entitled “SmallIncision Cataract Lens” which is hereby incorporated by reference, andU.S. Provisional Patent Application Serial No. 60/344,615 filed Dec. 31,2001, entitled “Intraocular Lens” which is hereby incorporated byreference, and U.S. Provisional Patent Application Serial No. 60/385,006filed May 31, 2002, entitled “Small Incision Cataract Lens and Methodsof Use Thereof” which is hereby incorporated by reference, and thisapplication also is a continuation-in-part application of U.S. patentapplication Ser. No. 09/441,425 filed Nov. 16, 1999, now U.S. Pat. No.6,488,707, entitled “Method of Implanting a Deformable IntraocularCorrective Lens,” which is hereby incorporated by reference, which is adivisional application of U.S. patent application Ser. No. 08/914,767filed Aug. 20, 1997, now U.S. Pat. No. 6,096,077, entitled “DeformableIntraocular Corrective Lens” which is hereby incorporated by reference.

Be it known that we, Wayne B. Callahan, a citizen of The United States,residing at 18952 Middle Drive, Abingdon, Va. 24211; and Jeffery S.Callahan, a citizen of The United States, residing at 104 Eagleview Dr.Blountville, Tenn. 37617 have invented a new and useful “Small IncisionLens.”

FIELD OF THE INVENTION

The present invention relates generally to the area of intraocular lensand use thereof to correct visual problems. More particularly, thisinvention provides a lens and method of use thereof for the correctionof a lack of accommodation. The lens can be inserted into a human eyethrough a 1.5 millimeter or smaller incision.

BACKGROUND OF THE INVENTION

Doctors trained in ophthalmology routinely surgically extractcataract-impaired natural crystalline lenses from patients'eyes andsubsequently implant artificial lenses to prevent blindness.

Using an intraocular lens for correction of visual problems is currentlyproblematic. In order to insert an intraocular lens, an incision is madethrough the cornea or sclera. The new lens is passed through theincision into the anterior chamber of the eye. The inserted lens is thenpositioned over the pupil and anchored either anteriorly to orposteriorly from the iris, or other structure of the eye. Unfortunately,the making of the incision causes astigmatism of the cornea.

Alternative lens materials are also currently used for the replacementsof the natural lenses of cataract patients. One such alternative lensmaterial is an acrylic that has a lower molecular weight than PMMA. Thislower-weight acrylic lens is softer than PMMA so it can be folded in aU-shape. However, if not handled very carefully, the lower-weightacrylic will crease, rendering it unusable. In addition, the material issoft enough to adhere to itself if it is rolled or folded far enough toallow overlapping.

Another alternative lens material is silicone, the same material that isused in breast implants. The silicone collects protein in some patients,giving a yellow appearance and reducing the passage of light. Theprotein can become so dense as to create the appearance of a secondarycataract, significantly reducing the patient's ability to see. This isusually a lesser concern for cataract patient, when compared to theblindness, which would result from the cataract. Also, most cataractpatients tend to be elderly so the protein build-up might not advancetoo far during their lifetimes. For some cataract patients, though, theprotein build-up necessitates that the silicone lens be removed andreplaced. Because of the problems associated with protein build-up,silicone cannot be used to make long-term intraocular lenses forimplantation into younger persons.

Two inventions for a deformable intraocular lens are set forth in U.S.Pat. No. 4,573,998 issued March 1986, to Mazzocco; and U.S. Pat. No.5,522,890 issued June 1996, to Nakajima et al. These inventions employ alens made of a molded elastic material. They do not suggest the use ofPMMA, nor do they suggest rolling an extremely thin lens to allow anincision size considerably smaller than required for the folded lens.

Other inventions generally related to the art of optical lenses include:U.S. Pat. No. 4,254,509 issued March 1981, to Tennant (AccommodatingIntraocular Implant); U.S. Pat. No. 4,585,456 issued April 1986, toBlackmore (Corrective Lens for the Natural Lens of the Eye); U.S. Pat.No. 4,655,775 issued April 1987, to Clasby (Intraocular Lens withRidges); U.S. Pat. No. 4,769,035 issued September 1988, to Kelman(Artificial Lens and the Method for Implanting Such Lens); U.S. Pat. No.4,795,462 issued January 1989, to Grendahl (Cylindrically Segmented Zoneof Focus Artificial Lens); U.S. Pat. No. 4,816,032 issued March 1989, toHetland (Arrangement in an Intraocular Anterior Chamber Lens); U.S. Pat.No. 4,950,290 issued August 1990, to Kamerling (Posterior ChamberIntraocular Lens); U.S. Pat. No. 4,994,080 issued February 1991, toShepard (Optical Lens Having at Least One Stenopaeic Opening Located inthe Central Area Thereof); U.S. Pat. No. 5,076,684 issued December 1991,to Simpson et al. (Multi-Focal Diffractive Ophthalmic Lenses); U.S. Pat.No. 5,098,444 issued March 1992, to Feaster (Epiphakic Intraocular Lensand Process of Implantation); U.S. Pat. No. 5,166,711 issued November1992, to Portney (Multifocal Ophthalmic Lens); U.S. Pat. No. 5,229,797issued July 1993, to Futhey et al. (Multifocal Diffractive OphthalmicLenses); U.S. Pat. No. 5,258,025 issued November 1993, to Fedorov et al.(Corrective Intraocular Lens); U.S. Pat. No. 5,480,428 issued January1996, to Fedorov et al. (Corrective Intraocular Lens). None of theseinventions solves the above-disclosed problems associated with currentlyknown deformable intraocular lenses.

SUMMARY OF THE INVENTION

A deformable artificial intraocular lens for implantation into the humaneye is disclosed herein. The lens is used for the correction of myopia,hyperopia, presbyopia, astigmatism, or for implantation after cataractsurgery. The lens optic consists of one smooth optical surface. Thesecond optical surface is a series of annular concentric rings. Therings allow the lens to have extremely thin edges, which reduce glare,halos, and distortion. The rings also allow the overall thickness of thelens to be significantly thinner than a standard lens. This allows thelens to be inserted through an incision of 1.5 millimeters or smaller. Astandard lens currently passes through an incision that is approximately3 millimeters. The rings on the second surface are adjusted to reducethe spherical aberrations from the design of the first surface opticbeing spherical. Such a thin lens also reduces coma, and other ThirdOrder Theory Aberrations (Fundamentals of Optics, Francis A. Jenkins andHarvey E. White, Fourth Edition, Copyright by McGraw-Hill, Inc. 1950renewed in 1957 and 1976, page 151 through 160), which also create halosand glare.

Also disclosed herein is a method of correcting a loss of accommodationcomprising removing a natural crystalline lens from the eye andinserting an intraocular lens in the eye. In certain embodiments, themethod further comprises unrolling the intraocular lens so that a hapticfootplate contacts the natural lens sac or the ciliary body in order tohold the intraocular lens in position and produce a minimum radial forceon the eye.

Accordingly, one aspect of the present invention is an intraocular lens,comprising an optical portion having a first optical surface, whereinthe optical portion is constructed of a material which is biologicallycompatible with a tissue of an eye, the optical portion having apredetermined maximum thickness under which the material may be rolledwithout exceeding the elastic limit of the material, said opticalportion having a predetermined minimum thickness above which thematerial retains said normal shape, wherein the intraocular lens isdeformed for passage through an incision having a length smaller thanabout 1.5 millimeters so that the intraocular lens is placed into theeye; the optical portion having a second optical surface, wherein thesecond optical surface comprises a central disk which is radiallysurrounded by a series of annular rings, the central disk and the seriesof annular rings forming a series of radial steps along the secondoptical surface so that a focal length from an annular ring is adjustedto focus at a same point as a prime meridian of the lens, wherein thesecond optical surface and the first optical surface have a minimumseparation of 0.025 mm and a maximum separation of 0.45 mm; and ananchoring portion attached to the optical portion, wherein the anchoringportion is constructed of a material which is biologically compatiblewith a tissue of an eye, wherein the anchoring portion is capable ofbiasing against a support structure of the eye. In certain embodiments,the second optical surface and the first optical surface have a minimumseparation of 0.025 mm and a maximum separation of 0.065 mm.

Another aspect of the present invention is that the first opticalsurface and the second optical surface are of a predetermined convexityfor obtaining a particular focusing power. In certain embodiments, thefirst optical surface and the second optical surface are of apredetermined concavity for obtaining a particular focusing power. Instill other embodiments, the first optical surface is of a predeterminedconvexity for obtaining a particular focusing power, and the secondoptical surface is of a predetermined concavity for obtaining aparticular focusing power. In other embodiments, the first opticalsurface is of a predetermined concavity for obtaining a particularfocusing power, and wherein the second optical surface is of apredetermined convexity for obtaining a particular focusing power. Inyet another embodiment of the present invention, the first surface is ofa predetermined concavity for obtaining a particular focusing power, andwherein the second optical surface is of a predetermined concavity forobtaining a particular focusing power.

Another aspect of the present invention is the ultra thinness of theanchoring portion. In certain embodiments, the anchoring portion has athickness of about 10 microns to about 100 microns. In otherembodiments, the anchoring portion has a maximum thickness of about 100microns. In other embodiments, the anchoring portion comprises aplurality of anchoring footplates or a plate haptic.

Still another aspect of the present invention is a lens constructed ofan acrylic material, a hydrophilic acrylic material, a hydrophobicacrylic material, any semi-rigid material having a thickness that isless than the elastic limit of the semi-rigid material, hydrogel,polymethylmethacrylate, or a material having an index of refraction fromabout 1.4 to about 2.0.

Another aspect of the claimed invention is the method of using theintraocular lens. In certain embodiments, a method of correcting avisual defect is provided. The method includes providing an intraocularlens as described herein, warming the intraocular lens to a temperaturefrom about 90 degrees F. to about 150 degrees F., making an incisionhaving a length of less than 1.5 mm in an eye, removing a natural lensof the eye, deforming the intraocular lens, cooling the intraocular lensto a temperature from about 60 degrees F. to about 80 degrees F.,inserting the intraocular lens into the eye through the incision,contacting the intraocular lens with an intraocular fluid within the eyeso that the intraocular lens warms and unrolls, and positioning theintraocular lens so that the anchoring portion biases against thesupport structure of the eye. In certain embodiments, positioning theintraocular lens further comprises biasing the anchoring portion againstan anterior and posterior capsule structure, wherein biasing produces aminimum radial force on the eye. In still other embodiments, positioningthe intraocular lens further comprises biasing the anchoring portionagainst zonules and a posterior iris, wherein biasing produces a minimumradial force on the eye, so that the anchoring portion of theintraocular lens is held in a fixed position.

Another aspect of the present invention is deforming the intraocularlens. In certain embodiments, the lens is rolled around a rod. In otherembodiments, the lens is rolled around itself. In certain embodiments,the incision is repaired.

Once rolled and passed through the cornea, the implanted intraocularlens may be placed in a position. In certain embodiments, the implantedlens may be positioned anterior to the iris, in the anterior chamber ofthe eye. If this position is chosen, the haptic edge of each of thehaptic fingers will be biased against the anterior chamber angle 31, theangle formed by the cornea and root of the iris and behind thetrabeculum. Once positioned and allowed to unroll, the implanted lenswill return to its original shape.

Alternatively, the implanted lens may be positioned posteriorly from theiris, and rest in front of the capsule of the natural lens of the eye.If this position is chosen, the haptic edge of each of the hapticfingers will be biased against the zonules and posterior iris surface orciliary sulcus. The implanted lens is able to be placed posteriorly fromthe iris because of the thinness of the implanted lens.

The lens may also be implanted into the capsule that contained thenatural lens after removal of the natural lens. One reason for theremoval of the natural lens is a clouding of the natural lens, cataract.A second reason for removing the natural lens is to allow placement ofan intraocular lens for cases of poor visions caused by extreme cases ofmyopia or hyperopia.

Another aspect of the present invention is using the lens disclosedherein to correct visualization of glare, halos, to reduce coma, and tocorrect spherical aberrations. In certain embodiments, the lens moves inorder to correct a lack of accommodation. In certain embodiments, theintraocular lens moves toward an anterior surface of the eye when aciliary muscle in the eye relaxes

While positioning the intraocular lens, in certain embodiments, theanchoring portion is curled toward the anterior surface of the capsulestructure. In other embodiments, the anchoring portion is curled towardthe posterior surface of the capsule structure.

Another aspect of the invention is a lens having a marker to indicatethe direction of the lens.

The present invention is a deformable intraocular lens that may berolled or folded for insertion into the human eye to correct commonvision problems or for the replacement of the natural lens aftercataract surgery. The lens is deformable because all portions of thelens are manufactured to a thickness, which is within a predeterminedrange of thicknesses. More particularly, at the first end of the range,the thickness of the lens is less than a maximum material thickness, thethreshold under which the material is flexible. At the second end of therange, the thickness of the lens is also greater than a minimum materialthickness, the threshold above which the lens material will retain itspre-flexed shape subsequent to flexing. The novel design also enablesthe deformable lens to possess any desired convexity or concavity, whichwould be required for correction of visual problems. Of course, thedeformable lens of the present invention may also be constructed fromany other biologically compatible material that can be manufacturedthinner than a pre-determined maximum material thickness to be rolled orfolded for passage through a small incision in the cornea or sclera.

An anchoring portion is attached to the optical portion to securelyposition the deformable intraocular contact lens, anteriorly to thenatural lens of the eye. In certain embodiments, the lens also has anon-optical transition area interconnecting the anchoring means to theoptical portion of the lens. The transition area has a thickness ofapproximately 0.025 mm. The anchoring means comprises a pair of hapticfingers extending from the transition area and circumvolving the opticallens. The thickness of the haptic fingers is preselected to provide theoptimal combination of strength and flexibility. The outer circumferenceof the haptic finger comprises the haptic edge. The haptic edge of theimplanted lens is biased against the intraocular tissues. The thicknessof the haptic edge is preselected to provide minimal stress to the eyetissues.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of the lens 10 with an ultra thin optic andhaptic. Also shown are the central disk 12, the series of annular rings14, the thin edge of the optical portion 16, an anchoring portion 50, inthis case a haptic 18, and an anchoring footplate 20, also called ahaptic footplate. The anchoring portion of the lens is thinner than theoptical portion. In this figure, there are five footplates. The lens 10is constructed of material that is biologically compatible with thetissue of the eye. As shown, the haptic 18 circumvolves, or surrounds,the optical portion 48 of the lens 10. Each anchoring footplate 20biases against a support structure that is used for attachment to theeye.

FIG. 2 is a sectional view of a lens 10 with a convex first opticalsurface 49. This view illustrates the ultra thinness of the lens 10including the anchoring portion 50. In this figure the haptic 18 has anangle greater than zero.

FIG. 3 is a sectional view of a lens 10 with concave first opticalsurface 149. Again the view illustrates the ultra thinness of the lens10.

FIG. 4 is a sectional view of a lens 10 showing the detail of the seriesof annular rings 14, including each individual annular ring 54, thefirst section of the annular ring 56, and the second section of theannular ring 58.

FIG. 5 is a plan view of a lens 10 with a plate haptic 22. This figureillustrates one of the different types of ultra thin haptics that can becoupled with the thin optic design to form lenses that will fit throughan incision that is smaller than 1.5 millimeters. The width 92 can varyfrom about 5 millimeters to about 8 millimeters. The length 90 can varyfrom about 10 millimeters to about 14 millimeters.

FIG. 6 is a sectional view of the plate style lens. Although an angle 94is shown, and represents, an angle of +10 degrees, the angle 94 can varyfrom about +10 degrees to about 0 degrees. The lens can be implantedwith the smooth, first surface 46 facing anteriorly or posteriorly. Forrefractive lenses the continuous surface is normally implanted facinganteriorly toward the cornea 96. When used as a cataract lens the lensis implanted with the continuous surface positioned posteriorly.Therefore, when the haptic is angled the angle is positive when thecontinuous surface is facing anteriorly and negative when the continuoussurface is facing posteriorly. This figure also shows a biconvex lens,having a convex first optical surface 49 and a convex second opticalsurface 51.

FIG. 7 is a modified plate lens wherein the anchoring portion 50 isdisplayed as ultra thin plate haptic. This haptic can be used with thethin optic design shown in FIGS. 2 and 3. The markers 24 in the lenshaptic are used for positioning and are well known in the art. Themarkers 24, also called teardrop openings, in the haptic indicate whenthe lens is in the correct position. In this figure, the markers 24point clockwise. In other embodiments, the markers 24 pointcounterclockwise. Accordingly, the markers 24 indicate orientation.

FIG. 8 is a cross section of the modified ultra thin plate haptic 22lens 10 used in the preferred embodiment.

FIG. 9 shows a lens 10 in an aphakic eye with the thinner section of thehaptic 20 rolling in the capsule 34. The lens 10 is positioned againstthe posterior surface 38 of the capsule 34 and held in position by thehaptic footplates 20 resting against the posterior surface 38 of thecapsule 34 and the anterior surface 36 of the capsule 34. With time, theanterior and posterior capsules grow together and the lens is furtherfixated in the eye since the tissue from the anterior and posteriorsegment grow together through the positioning markers 24, as shown inFIG. 7.

FIG. 10 shows a lens 10 in an aphakic eye wherein the thinner section ofthe haptic 20 accordions in the sac.

FIG. 11 shows the detail of the anchoring footplate 20 rolling towardthe anterior portion of the eye. Note that the anchoring footplate 20,in this embodiment serving as the anchoring portion, is biased againstthe anterior surface 36 of the capsule 34 and the posterior surface 38of the capsule 34.

FIG. 12 shows the detail of the anchoring footplate 20 rolling towardthe posterior portion of the eye. Note that the anchoring footplate 20,in this embodiment serving as the anchoring portion, is biased againstthe anterior surface 36 of the capsule 34 and the posterior surface 38of the capsule 34

FIG. 13A shows the detail of the anchoring portion 50 of the lens 10biasing against the zonules 42 and the posterior surface 32 of the iris28. The anchoring portion 50 is rolling toward the anterior portion ofthe eye.

FIG. 13B shows the detail of the anchoring portion 50 of the lens 10biasing against the zonules 42 and the posterior surface 32 of the iris28. The anchoring portion 50 is rolling toward the posterior area of theeye.

FIG. 14 shows the axis of motion 37 of the lens 10 relative to the eye.

FIG. 15 shows a cross sectional view of an eye. The figure shows thenatural crystalline lens 11 of the eye, the anterior chamber of the eye26, the posterior chamber of the eye 27, the iris 28, the anteriorsurface of the iris 30, the posterior surface of the iris 32, theanterior surface 36 of the natural lens sac 34, the posterior surface 38of the natural lens sac 34, the zonules 42, and the ciliary body 40.

FIG. 16A is an intraocular lens 10 as described by the current inventionbeing rolled around a rod 43. The lens 10 was just removed from a vialcontaining a balanced salt solution, BSS, which was heated toapproximately 100 degrees F. The lens 10 must be rolled immediatelyafter removal from the warm BSS, since the material becomes stiff whencooled or dehydrated.

FIG. 16B shows the lens 10 which has slightly penetrated the incision,also called the wound 66, which is smaller than 1.5 mm in length, of theeye 15.

FIG. 16C shows the lens 10 inside the eye 15. Once inside the eye 15,the lens 10 will come in contact with the warm aqueous, or intraocularfluid, of the human eye 15 and immediate begin unrolling, which takesapproximately 15 seconds.

FIG. 17 shows a standard lens 76 with a typical thickness for a givenpower of 20 diopter when using a material with an index of refractionfor 1.47. The figure depicts a ray of light 80 entering the lens at theapex of the lens and passing through the lens without being refracted,which is known as the prime meridian and is along the central axis ofthe lens. A second ray 82 one millimeter from the prime meridian andparallel to the prime meridian is shown where the refraction is suchthat the ray comes to a focal point before the prime meridian. Thecalculations in table 2 show that the focal point of the second ray 82entering the lens one millimeter from the prime meridian focusesapproximately one millimeter before the prime meridian focal point. Athird ray 84 entering the standard lens 76 two millimeters from theprime meridian is shown to focus approximately 3 millimeters before theprime meridian.

FIG. 18 depicts a ray of light 80 entering the lens at the apex of thelens 10 and passing through the lens without being refracted, which isknown as the prime meridian and is along the central axis of the lens.The figure also shows that by adjusting the power on the second opticalsurface 51 with each ring 54, the focal point of the prime meridian andthe third ray 84 entering the lens 10 of the present invention twomillimeters from the prime meridian focus at the same point. Therefore,spherical aberrations are reduced.

FIG. 19 provides a graphical depiction of the angles described in thecalculations for spherical aberration for a twenty-diopter lens madefrom a material with an index of refraction of 1.47.

FIG. 20 shows a condition called coma, in which light from ray one 68travels for over 2.2 millimeters within the standard lens 76 and lightfrom ray two 70 is only passing through the lens for a distance of 1.96millimeters. Coma appears as a comet or ghost image. The extremely thinlens 10 of the current invention should eliminate much of the coma.

FIG. 21 shows light 72 entering a standard lens 76. The light 72 isrefracted by the first surface 73. The refracted light travels towardthe second surface 75. Most of the light 72 is refracted by the secondsurface 75 of the standard lens 76 and the refracted light 77 exits thelens, but a small portion is reflected light 78 which moves toward thefirst surface 73 of the standard lens 76. Most of the light is refractedagain by the first surface 73, but a portion of the reflected light 78is reflected again such that the reflected light 79 moves to the secondsurface 75 and again is refracted by the second surface 75 so that thelight 81 exits the lens. Several harmonics of the distortion can occur.Each additional image that is projected from the second surface 75 isout of phase with the original refracted ray 77, which will causedistortion.

FIG. 22 shows a cross section view of an embodiment of the invention inwhich the first surface 46 and the surfaces of the central disk 12 andeach of the annular rings 54 are convex.

FIG. 23 shows a cross section view of an embodiment of the invention inwhich the first optical surface 149 and the surfaces of the central disk112 and each of the annular rings 154 are concave.

FIG. 24A shows a cross section view of an embodiment of the invention inwhich the first surface 46 is convex and the surfaces of the centraldisk 12 and each of the annular rings 54 are convex.

FIG. 24B shows a cross section view of an embodiment of the invention inwhich the first optical surface 49 is convex and the surfaces of thecentral disk 112 and each of the annular rings 154 are concave.

FIG. 25 shows a cross section view of an embodiment of the invention inwhich the first optical surface 49 of the optical portion 48 and thesurface of the central disk 12 are convex. The outer surface 159 of eachannular ring 154 is concave.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Many visual problems can only be corrected by removing the natural lensfrom the eye and replacing it with an intraocular lens. Although suchlens replacement will enhance the visual ability of the patient, thelenses described in the prior art often create secondary visualproblems. For example, many patients have difficulty driving at nightdue to glare, halos and rings from on coming automobile headlamps,taillights and street lamps. The secondary visual problems often comefrom Third Order Aberrations (Fundamentals of Optics by Francis A.Jenkins and Harvey E. White, copyright renewed 1965, Library of congressISBNO-07-0323330-5, pages 151 and 152), which, in general, are the sumof the light ray deviations from the path as to allow all light raysacross the lens surface to focus at the focal point of the primemeridian. The Gaussan formulas errors increase as the distance from theprime meridian increases. The formulas also assume an infinitesimallythin lens, which would eliminate coma and other aberrations. The errorsassociated with the Gaussan formulas are expressed in terms of five sumscalled the Seidel sums. The Seidel sums include spherical aberrations,coma, distortions, astigmatism and curvature of field.

The intraocular lens and methods of use thereof, which are describedherein, resolve much of the secondary visual problems created by ThirdOrder Aberrations that commonly occur. Briefly, the intraocular lens 10has a series of annular rings 14 and a maximum thickness which allow thelens 10 to be rolled, squeezed, or otherwise compressed for insertionthrough a corneal incision, or incision of sclera, of less than 1.5millimeters. Each annular ring 54 has two sides arranged as shown inFIGS. 2, 3, 4, 6, 8, 18, 22, 23, and 24. Additionally, the thinconstruction of the lens 10 and haptic 18 allows the lens 10 to movewithin the location of insertion in order to correct a lack ofaccommodation.

As used herein, “aphakic eye” means an eye with the natural lensremoved.

As used herein, “phakic eye” means an eye with the natural lens still inplace.

As used herein, “support structure of the eye,” means a structure of theeye where a lens can be placed. The following are examples of supportstructures. These examples do not exclude other support structures thatare not mentioned. The anterior angle 31 of the anterior chamber 26 ofthe eye, as shown in FIGS. 9-13, is the area at the far end of thecornea 96 and iris 28 where the two structures come together. Anotherexample of a support structure includes the ciliary cavity 45, alsoshown in FIGS. 9-13, which is defined as the area where the zonules 42attach to the ciliary body 40 and the posterior surface of the iris 32.The lens can also be placed in the capsule 34 remaining after removingthe natural lens. When the lens is placed in the capsule 34 left afterremoving the natural lens, the anchoring portion rests against theposterior surface 38 of the capsule 34 and the anterior surface 36 ofthe capsule 34.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention pertains. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, the preferred methods andmaterials are described below. All publications, patent applications,patents, and other references mentioned herein are incorporated byreference in their entirety. Unless otherwise indicated, materials,methods, and examples described herein are illustrative only and notintended to be limiting.

Until the development of the current invention, the existence of a trulythin lens was consider theoretical (Optical Engineering Fundamentals byBruce H. Walker, and edited by Donald C. O'Shea, George Institute ofTechnology. Published by SPIE Optical Engineering Press, A Publicationof SPIE—The International Society of Optical Engineering, Bellingham,Washington USA). On page 57, the aforementioned text states, “A thinlens is a lens whose thickness is assumed to be zero and therefore isnegligible. The thin lens is a design tool, used to simulate a real lensduring the preliminary stages of optical system design and analysis.”Later in the same paragraph the text states “By assuming a lens formwhere the thickness is zero, the formulas used to calculate object andimage relationships are greatly simplified. The drawback to thethin-lens approach is that it is not possible to determine image qualitywithout including the actual lens thickness (and other lens data) in thecalculations. As a result, while it is possible to establish manyvaluable facts about an optical system through the application of thethin-lens theory and formulas, the ultimate quality of the image can, atbest, only be estimated.”

The current invention is based on a lens that is thin enough to approachthe theoretical zero thickness, yet has enough thickness to support theoptical structure. This allows the thickness of the lens to be ignoredin calculations. Thus, the present invention discloses a lens thatapproaches a theoretically perfect lens.

The Gaussan lens theories (Fundamentals of Optics, Jenkins and White,page 48) assume the power of a lens is equal to the difference betweenthe indexes of refraction of the lens material and the media in whichthe lens is surrounded divided by the radius of curvature of the lenssurface.

As seen in FIG. 1, the present invention discloses a lens 10 having anoptical portion 48 and an anchoring portion 50. The optical portion 48has a first optical surface 49 and a second optical surface 51. Incertain embodiments, the optical portion 48 of the lens 10 has abiconvex structure, as best seen in FIGS. 2, 6, 8, 22, and 24A. In otherembodiments, the optical portion 48 of the lens 10 has a biconcavestructure, as seen in FIG. 23. In still other embodiments, the opticalportion 48 has a convex first optical surface 49 and a concave secondoptical surface 151, as shown in FIG. 24B. In certain embodiments, notethat a convex second is optical surface 51, further comprises a convexcentral disk 12 and annular rings 54 having convex outer surfaces 59, asshown in FIG. 24A. In other embodiments, a concave second opticalsurface 151, further comprises a concave central disk 112 and annularrings 54 having concave outer surfaces 159, as shown in FIG. 24B. Thepredetermined convexity or concavity of the outer surface 59 of theannular ring 54 adjusts the focal length of the annular ring to focus ata same point as a prime meridian of the lens. In other embodiments, theoptical portion 48 has a concave first optical surface 149 and a convexsecond optical surface 51, as shown in FIG. 3. Reference number 49represents a first optical surface having a convex shape. Referencenumber 149 represents a first optical surface having a concave shape.Claim language referencing the first optical surface could apply toeither. Reference number 51 represents a second optical surface having aconvex shape. Reference number 151 represents a second optical surfacehaving a concave shape. Claim language referencing the second opticalsurface could apply to either.

In another embodiment, as shown in FIG. 25, the first optical surface 49of the optical portion 48 and the central disk 12 are of a predeterminedconvexity for obtaining a particular focusing power and the outersurface 159 of each annular ring 154 is of a predetermined concavity.The shape of the outer surface 159 adjusts the focal length from theannular ring 154 to a same point as a prime meridian of the lens 10.

In certain embodiments, the intraocular lens 10 has a first surface 46that is convex. Generally, as seen in FIGS. 1-8 and 22-24, the secondsurface 44 of the lens 10 comprises a planar, central disk 12 which issurrounded by a series of concentric, planar, annular rings 54 ofincreasing diameter. The annular rings 54 are parallel to each other andto the central disk. The central disk 12 and annular rings 54 are alsoperpendicular to a radial axis passing though the apex of the firstsurface. In combination, the central disk 12 and the series of annularrings 14 form a series of steps extending radially from the disk acrossthe second surface 44 to maintain a close proximity to the first surface46.

In still other embodiments, the thickness of the lens between thecentral disk of the second surface and the apex of the first surfacemust be less than a predetermined maximum thickness. The predeterminedmaximum thickness is the thickness under which the material may berolled or folded without exceeding the elastic limit of the selectedlens material.

In still other embodiments, the thickness of the lens at the peripheryof the central disk must be greater than a predetermined minimumthickness. The predetermined minimum thickness is the thickness abovewhich the lens material will retain its pre-flexed shape subsequent toflexing. The minimum thickness is determined by the manufacturingprocess and the strength of the lens material.

The radial width of the central disk 12 of the second surface 44 alsofalls within a predetermined range. The thicker the lens is at its apex,the farther the radial width may extend before the periphery of thecentral disk 12 approaches the predetermined minimum thickness. Thespecific range of radial widths is determined by both the convexity ofthe first surface and the thickness of the lens at its apex.

Similar to the central disk 12, the thickness between the first surface46 and the second surface 44 of the lens 10 at the internal diameter ofeach annular ring, or most distal point, should be less than or equal tothe predetermined maximum thickness. The thickness between the firstsurface and the second surface of the lens at the external diameter ofeach annular ring, or closest point, should be greater than or equal tothe predetermined minimum thickness. The radial width of the annularrings will be within a predetermined range of lengths, which isdetermined by the convexity of the first surface and the thickness ofthe lens at the internal diameter of the annular ring. The greater thethickness of the lens at the internal diameter of the annular ring, thegreater the radial length may be extended before the exterior diameterapproaches the predetermined minimum thickness.

If an imaginary line is drawn to connect the second surface's internaldiameters of the annular rings, which is the point most distant from theanterior surface, and the center of the central disk, the imaginary linewill form an arc or parabola, depending on the various thicknesseschosen. This imaginary line forms the effective second surface 44. Bychanging the thicknesses and widths of the central disk and annularrings, the effective second surface may be shaped as desired. This isparticularly relevant for applications in which the implanted lens isimplanted posterior from the iris. This is because the effective secondsurface may thereby be constructed in a predetermined shape, whichenables the implanted lens to be properly near the anterior surface ofthe natural lens capsule.

As shown in FIG. 24A, in one alternate embodiment of the invention, thecentral disk 12 and each annular ring 54 of the second optical surface51 are not planar. Rather, each surface of the central disk 12 and theouter surface 59 of each annular ring 54 is convex. In a secondalternate embodiment of the invention, as shown in FIG. 24B, eachsurface of the central disk 112 and outer surface 159 of each annularring 154 is concave. Thereby, particular degrees of convexity orconcavity of each section of the second optical surface 151 may bechosen to further help obtain particular focusing powers for differentlenses. Reference number 59 represents the outer surface of an annularring 54 of a lens 10 having a convex shape. Reference number 159represents the outer surface of an annular ring 54 of a lens 10 having aconcave shape. Claim language referencing the outer surface could applyto either. Reference number 12 represents the central disk of a lens 10having a convex shape. Reference number 112 represents the central diskof a lens 10 having a concave shape. Claim language referencing thecentral disk could apply to either. Also, in any of these embodiments,the central portion and annular rings 54 of the lens 10 may be of asymmetric or asymmetric ovular shape for correction of sphericalaberrations.

As best seen in FIGS. 4 and 22-24, the second surface 44 of the lens 10comprises a central disk 12, which is radially surrounded by a series ofannular rings 14, the central disk 12 and the series of annular rings 14forming a series of radial steps along the second surface 44. Eachannular ring 54 has a first section 56, a second section 58, and anouter surface 59, as shown in FIGS. 4 and 22-24. The thickness of thelens 10, or separation between the first section 56 of the annular ring54 located on the second surface 44 of the lens 10 and the first surface46, is less than or equal to the predetermined maximum thickness. Also,the thickness of the lens 10, or separation between the second section58 of the annular ring 54 located on the second surface 44 of the lens10 and the first surface 46, is greater than or equal to thepredetermined minimum thickness. The minimum separation distance fromthe first surface 46 to the closest point of the second surface 44, thesecond section 58 of an annular ring 54, is 0.025 millimeters. Themaximum separation distance from the first surface 46 to the mostdistant point of the second surface 44, the first section 56 of anannular ring 54, is 0.45 millimeters. Reference number 46 represents thefirst surface of a lens 10 having a convex shape. Reference number 146represents the first surface of a lens 10 having a concave shape. Claimlanguage referencing the first surface could apply to either.

In certain embodiments, the periphery of the optical portion comprises aparallel lenticular area. The parallel lenticular area is of uniformthickness. The parallel lenticular area prevents the phenomenon known asedge effects, which occurs if the optical portion of the lens does notadequately cover the periphery of the pupil. The edge effects areproduced in various situations including when overhead lights areilluminated in low lighting situations, such as in roadway tunnels.

The first optical surface 49 of the lens 10 is spherical as described inthe Gaussan lens theories, yet practical applications have shown thelens design creates spherical aberration as shown in FIG. 18. FIG. 17shows light rays 80, 82, and 84 entering a standard lens 76. Note thatthere is more spherical aberration as the distance from the primemeridian of the eye and lens increases. A practical consequence of thiscondition is the visualization of glare, halos, or rings. Specifically,in low light conditions, such as driving at night, the patient has amuch more open pupil. Accordingly, patients often report glare, halosand rings.

With the ultra thin lens 10 disclosed herein, as shown in FIG. 18, muchof the spherical aberration present in a standard lens is eliminated.Spherical aberrations cause images to have a ghost or second image.Headlights from on coming vehicles at night will show as a secondheadlamp or look much larger than actual. The same effect is true oftaillights as approaching an automobile. Street lamps can have the sameeffect. The condition is severe enough in many patients that no attemptis made to drive at night. This is also true of people who wear contactlenses or spectacles.

The following information shows the calculations for sphericalaberration for a twenty-diopter lens made from a material with an indexof refraction of 1.47.

P = 20 Total Lens Power N_(lens) = 1.47 Index of refraction of thematerial N_(aqueous) = 1.336 Index of refraction of the aqueous of thehuman eye R_(total) = (N_(lens) − N_(aqueous))*1000/P_(s) Formulaassumes one equivalent radius for the lens R_(total) = 6.7 Surfaceradius Fl_(PM) = N_(lens)/P_(surface) Focal length of the lens along theprime meridian     = 73.5 Focal length calculated Sin Angle Angles arein radians Fl_(1 mm) Calculations of the focal length for a ray enteringthe eye one millimeter from the prime meridian. φ₁ = 0.149254 0.149814Angle 1 formed by parallel light entering the lens and the angle madewith the radius of curvature of the lens at the point of contact of theparallel light. In this the calculation one millimeter from the primemeridian φ₂ = 0.135648 0.136068 Angle 2 Formed by the light ray as it isrefracted and bent in portion to the indexes of refraction of the lensmaterial and aqueous. φ₃ = 0.013605 0.013746 Angle 3 Resulting anglebetween the prime meridian and the refracted light ray. Fl_(1 mm) =72.75212  72.74525  Focal length of the light ray entering the eye atone millimeter from the prime meridian. D Fl_(1 mm) = 0.747881 0.754754Difference in the focal length of the prime meridian and the ray thatentered the eye one millimeter from the prime meridian. Fl_(2 mm) =Calculations of the focal length for a ray entering the eye twomillimeter from the prime meridian. φ₁ = 0.298507 0.303128 Angle 1formed by parallel light entering the lens and the angle made with theradius of curvature of the lens at the point of contact of the parallellight. In the calculations two millimeters from the prime meridian wasselected as the contact point. φ₂ = 0.271297 0.27474  Angle 2 Formed bythe light ray as it is refracted and bent in portion to the indexes ofrefraction of the lens material and aqueous. φ₃ = 0.028389 Angle 3Resulting angle between the prime meridian and the refracted light ray.Fl_(2 mm) = 70.45092  70.43199  Focal length of the light ray enteringthe eye at two millimeters from the prime meridian. D Fl_(2 mm) =3.04908  3.068006 Difference in the focal length of the prime meridianand the ray that entered the eye one millimeter from the prime meridian.

The index of refraction of many of the poly hema materials isapproximately 1.47. The calculations were based on one lens surfacehaving all the power without showing thickness. This is often done torepresent simplified calculations of the lens formula and isapproximately accurate to show proof of principle. Therefore, all thepower was put into one lens surface and the radius for a 20-power lensis 6.7 millimeters. The radius is determined by dividing the desiredpower into the difference between the index of refraction of thesurrounding media of the lens and the lens index of refraction. Theresultant is multiplied by 1000 to convert from meters to millimeters.The focal length of the prime meridian is the resultant of dividing thepower into the index of refraction of the material and for the givenconditions is 73.5 millimeters. Angle one 82, angle two 84 and anglethree 86 described above are depicted in FIG. 19. The angle between thegiven radius and the ray that contacts the lens at that point is angleone 82. Angle one 82 will vary in value as the distance from the centerof the lens the ray being evaluated contacts the lens. Angle two 84 isthe angle determined by the formula shown above for determining theamount of refraction. The amount of refraction is a measure of the ratioof the sine of the angles being equal to the ratio of the refractiveindexes of the materials. Angle two 84 is the index of refraction of theaqueous divided by the index of refraction of the lens material timesthe sine of angle one. Note for small angles, the sine of the angle andthe angle are approximately equal. The calculations show all angles inradians. Angle three 86 is the angle the refracted ray makes with theprime meridian 80 and is the result of subtracting angle two from angleone. The focal length of the ray entering one millimeter from the primemeridian is obtained by dividing the tangent of angle three into one.The focal length for the ray entering two millimeters from the primemeridian is calculated in a like manner. The difference in the focallength of the prime meridian and the ray entering one millimeter fromthe prime meridian is approximately 0.75 millimeters short of the primemeridian. The difference in the focal length of the prime meridian andthe ray entering two millimeters from the prime meridian isapproximately 3 millimeters short of the prime meridian.

The current invention adjusts the radii of curvature on the secondsurface 44 of the lens 10 to allow the focal point of the rays to beapproximately the same as the prime meridian. By doing so, much of thespherical aberration is eliminated.

As best seen in FIG. 20, the second of the Third Order Aberrations iscoma (Fundamentals of Optics, Jenkins and White, page 162). Coma isdescribed as an off axis spherical aberration, which means that lightenters the eye at an angle such that some rays of light travel throughthe lens longer than other rays. According to the text Clinical Optics,the condition called coma “is spherical aberration applied to lightcoming from points not lying on the principal axis. Rays passing throughthe periphery of the lens are deviated more than the central rays andcome to a focus nearer the principal axis. This results in unevenmagnification of the image formed by different zones of the lens.” (A.R. Elkington, H. J. Frank, and M. J. Greaney, Clinical Optics, ThirdEdition, page 96, Blackwell Science Ltd., Commerce Place 350 MainStreet, Malden Mass. 02148 5018, British Library Number ISBN0-623-04989-8, Library of Congress 99-20296). Authors Jenkins and Whitestate that this condition has the appearance of a commit, therefore thename coma. Coma, like spherical aberrations, causes the patient to seeglare halos and rings. Much of the coma is eliminated with the lens 10,described herein, since such a thin lens reduces the travel distance ofthe light inside the lens 10.

Another of the Third Order Aberrations is distortion. Distortion cancome from many sources, one of which is outlined in FIG. 21. As seen inFIG. 21, light 72 is refracted at the first surface 73 of a standardlens 76 and the refracted ray 74 travels through the lens material tothe second surface 75 of a standard lens 76. The refracted ray 74, uponcontacting the second surface 75 is refracted a second time and therefracted ray 77 exits the standard lens 76. However, some of the lightthat traveled the same path as the refracted ray 74 is reflected andsuch reflected light 78 travels toward the first surface 73. Again, aportion of the light is reflected by the first surface 73 of thestandard lens 76 and the reflected light 79 returns to the secondoptical surface where it was initially reflected. Note that the light 81is out of phase with the refracted ray 77 exiting the lens. Several suchharmonics can have an effect on the lens quality. The lens 10, describedherein will create less opportunity for the light to be out of phase.While some phase shift is still present, the shift is not as great withthe lens 10 of the present invention.

A fourth member of the Seidel sums and Third Order Aberrations isastigmatism of the lens. Most astigmatism was created in older lensesfrom the polishing process. Most modern intraocular lenses are tumblepolished in a process similar to a lapidary. If the cutting process isof excellent quality, then little astigmatism should be present in amodern intraocular lens.

The last of the Seidel sums is curvature of field (Fundamentals ofOptics, Jenkins and White, page 170). In previous discussions withinthis disclosure, we stated that light rays from the outside portion of astandard lens focus earlier than the rays from the center portion of thestandard lens. When projecting on a screen, curving the screen cancorrect the aberrations from curvature of field. The present inventionincludes correction of curvature of field in the corrections on thesecond optical surface 51 to correct for spherical aberrations.

All the aberrations focus light at a point other than the point wherethe prime meridian, located along the central axis of the lens, focuseslight. If all the aberrations are present in a lens, then the usefuldepth of field is reduced. Depth of field is defined as a “range (ofdistances) in which an image created by an optical system is acceptablysharp” (Dictionary of Eye Terminology, Third Addition, Barbara Cassinand Sheila A. B. Solomon, Triad Publishing Co, Gainesville, Fla., ISBN0-937404-44-6). By eliminating the aberrations, one can readily concludethe depth of field is greater. With a greater depth of field the patientcan see images clearer over a range of distances. Therefore, eliminatingthe aberrations increases depth of field and gives the patient betterability to clearly see objects near and far without additionalcorrections.

The following description of Hooke's Law is provided in order to explainwhy certain materials will bend without distortion before it reaches itselastic limit. According to Hooke's Law when a force is applied along anaxis the increase in length due to application of the force divided bythe original length of the member along the axis to which the force wasapplied is strain (Mechanics of Materials, p. 29, E. P. Popov, Professorof Civil Engineering University of California Prentice-Hall, Inc.Englewood Cliffs, N.J. copyrighted 1952 eight printing 1958). Strain isa dimensionless quantity and is very small except for materials such asrubber. Stress is the amount of force applied to a material divided bythe cross sectional area of the material where the stress was applied.When plotting a relationship between stress and strain, there is aportion of the diagram that is linear. The deflections where thestress-strain diagram is linear do not cause a permanent deformation ofthe material to which the stress was applied. For some materials, suchas cast iron and concrete, the portion of the curve where there is nopermanent deformation is extremely small. For some alloy steels thecurve is linear almost to the rupture point of the material. Up to somepoint the relationship between stress and stain may be said to be linearfor all materials. This is known as Hooke's Law.

Stress is directly proportional to strain and the constant ofproportionality is called the elastic modulus, modulus of elasticity, orYoung's modulus. The elastic modulus has been bench tested andcalculated for many materials and published in engineering and otherscientific handbooks. In the formula (Standard Handbook for MechanicalEngineers, p.5-42, Theodore Baumeister, Editor Lionel S. Marks, Editor,1916 to 1951. Mc Graw-Hill Book Company, New York), the amount ofdeflection is proportional to the applied force times the length of thedeflected object to the third power divided by the modulus of elasticitytimes a coefficient and the moment of inertia of the material beingdeflected.

The formula was used by the authors to calculate the maximum thicknessof a lens without exceeding the elastic limit of the material. The valuewas theoretical since the lens is a wafer or disc and not a true beam.In addition, the modulus used was for an acrylic, which is close topolymethylmethacrylate (PMMA). The theoretical calculations show themaximum thickness of the lens to be 0.25 millimeters. Wafers of PMMAwere manufactured by the authors to 0.25 millimeters, which had somepermanent deformation when rolled around a ⅛-inch, 3.175-millimeter rod.Test conducted by the authors showed the lens thickness was close tobeing correct. Next, the authors had lenses with the desired centraldisk 12 and series of annular rings 14 made; which were rolled by theauthors around the ⅛-inch rod. Again, some permanent deformation waspresent. The experiments were continued until the authors weresuccessful rolling a lens 10 having a maximum thickness of 0.1millimeters and a minimum thickness of 0.025 millimeters around a{fraction (1/16)}-inch, 1.5875-millimeter rod. A lens 10 with athickness of 0.1 mm is rolled around a {fraction (1/16)}-inch,1.5875-millimeter rod 43, as seen in FIG. 16A. Accordingly, in certainembodiments, a lens 10 having a maximum thickness from about 0.1 mm to aminimum thickness of about 0.025 mm is used in the invention describedherein. In other embodiments, the lens 10 has a maximum thickness fromabout 0.45 mm to a minimum thickness of about 0.025 mm. In still otherembodiments, the lens 10 has a maximum thickness from about 0.065 mm toa minimum thickness of about 0.025 mm. When the minimum thickness of thelens when measured from the front first surface to the closest minimumpoint along the second surface is less than 0.025, the lens sometimesfail from shear stress when an instrument to roll the lens is applied.The thin lens formula states

1/f=(N1−1)(1/R1−1/R2)

(Fundamentals of Optics, p. 67 and 70, Francis A. Jenkins and Harvey E.White, Fourth Edition, McGraw-Hill Book Company, copyright 1950 andrenewed in 1965)

'f=focal length of the lens

N1=index of refraction of the lens material

R1 is one radius of curvature expressed in meters

R2 is the second radius of curvature expressed in meters

The formula is for a lens in air. If the lens is in a media other thanair, such as aqueous of the human eye, or other intraocular fluid, theformula becomes

1/f=(N1−N2)(1/R1−1/R2)

Where N2 is the index of refraction of the media in which the lens isplaced. In this case the aqueous of the human eye.

The power of a lens is P=1/f

Where P is in diopter

'N1 for polymethylmethacrylate is 1.492

'N2 for aqueous is 1.336

Where Tc=the center thickness at the apex=0.1 millimeter

Pa=anterior power

Pp=posterior power

Pn=net power

Below is shown information for a lens where the negative power isexpressed net power. First, myopic lenses, followed by hyperopic lenses:

Center Pn Pa Pp Thickness Te_2 Te_3 −10  5 −15 0.1 0.23 0.40 −10 10 −200.1 0.23 0.41 −10 15 −25 0.1 0.24 0.43 −15  5 −20 0.1 0.30 0.56 −15 10−25 0.1 0.30 0.58 −15 15 −30 0.1 0.31 0.61 −20  5 −25 0.1 0.37 0.72 −2010 −30 0.1 0.37 0.76 −20 15 −35 0.1 0.38 0.82 −25  5 −30 0.1 0.44 0.91−25 10 −35 0.1 0.45 0.97 −25 15 −40 0.1 0.46 1.07

Cataract or Hyperopic Lens Pn Pa Pp Tedge Tcenter2 Tcenter3 10  5 5 0.20.33 0.49 10 10 0 0.2 0.33 0.49 10  5 5 0.2 0.33 0.49 15 10 5 0.2 0.390.64 20 10 10  0.2 0.46 0.78 25 10 15  0.2 0.52 0.93

Te_(—)2 is the distance along the edge of the lens parallel to thecentral axis and two millimeters from the central axis when the opticdiameter is four millimeters. Te_(—)3 is the distance along the edge ofthe lens parallel to the central axis and three millimeters from thecentral axis when the optic diameter is six millimeters. The distancefrom the apex of the anterior surface to the edge of the anteriorsurface measured parallel and offset to the central axis or primemeridian is expressed as Tr1. The distance from the apex of theposterior surface to the edge of the posterior surface measured paralleland offset to the central axis or prime meridian is expressed, as Tr2.Tc is the center thickness at the apex. The last column shows the edgethickness of the lens. Note the edge thickness, in the best case,approaches the theoretical maximum thickness to where PMMA will roll.From actual experiments, the material does not return completely to theoriginal shape i.e., there is some permanent deformation in the materialat 0.25-millimeter thickness. Therefore, the lens will not roll around a⅛-inch dowel pin and is not a deformable refractive lens. In fact,previously designed lenses do not have a constant thickness along theoptic surface where the anterior surface and the posterior surface areparallel to each other. With a thin lens, the radii of each surfaceapproximates each other so that both surfaces have the same power, whilethe anterior surface is positive and the posterior surface is negative,i.e. the lens powers cancel each other. Note when the lenses are madefrom a material such as a hydrogel, hydrophilic acrylic or hydrophobicacrylic the lenses flex with much more thickness than PMMA; and thethickness can be increased to approximately one half or less thicknessof a standard lens, so the mass is reduced with the current invention,which allows for the smaller incision.

In an article by Doctor Glasser (Glasser and Kaufman, Presbyopia: AView, The eMedicine Journal, Aug. 20, 2001, Volume 2, Number 8, pages1-15), within the introduction, the author states that presbyopia ischaracterized as a progressive, age-related loss of accommodativeamplitude. Complete loss of accommodation usually culminates by age 50years. Emmetropic patients have good far vision, but need correction fornear vision. Myopic patients near vision is less of a problem.

In the aforementioned article, Dr. Glasser discusses the theory ofaccommodation proposed by Helmholtz in 1909. The theory of accommodationtheorized that accommodation occurs when the ciliary muscle contracts torelease the resting zonular tension on the equatorial edge of the lens.Stated another way, the ciliary body 40, shown in FIG. 15, is smallerwhen the eye is looking far when compared to the size of the ciliarybody during visualization of objects that are near. The general anatomyof the eye is shown in FIG. 15. The smaller ciliary body 40 stretchesthe zonules 42, which are a form of ligaments. The stretched zonules 42in turn stretch the capsular sac 34 containing the natural crystallinelens 11, which makes the crystalline lens 11 flatter for far vision. Theflatter lens causes the images seen by the eye to focus on distantobjects. As the ciliary body 40 swells, the tension on the zonules 42,or ligaments, relaxes and the crystalline lens 11 takes a more naturalrounded shape, which allows near objects to focus. Dr. Glasser describesseveral theories as to why accommodation is reduced with age.Accommodation begins leaving the average person by 35 years of age andthe completely gone by age 60 years of age. By age 45 to 50 years of agethe average person will need reading spectacles or contact lens for nearvision.

In the last paragraph of section two of the introduction, the article byDr. Glasser goes on to say that experiments show that the ciliary musclemoves anterior-inward, and the equatorial edge of the lens moves awayfrom the sclera during accommodation. (Glasser and Kaufman, Presbyopia:A View, The eMedicine Journal, Aug. 20, 2001, Volume 2, Number 8, pages1-15). Videos using goniovideography were taken using accommodation,which the zonular fibers or ligaments relaxed during accommodation. Thearticle further states that imaging shows that the posterior zonularfibers, extending between the posterior attachment of the ciliary muscleand the ciliary processes, are stretched during accommodation by theforward and axial movement of the apex of the ciliary muscle.

In Section three, entitled Theories of Presbyopia, Dr. Glasser discussesseveral theories, which state why accommodation is lost. (Glasser andKaufman, Presbyopia: A View, The eMedicine Journal, Aug. 20, 2001,Volume 2, Number 8, pages 1-15). One of the two predominate suchtheories is that the crystalline structure of the natural lens becomesbrittle with age. Another theory is the loss of ciliary muscle andchoroidal elasticity. A similar theory is that the natural lens of theeye continues to grow with age until the muscles cannot over come theforce exerted by the lens to allow a change of shape.

If a surgeon removes a cataract early, then the crystalline lens is easyto chop into small segments and aspirate. If the cataract is allowed tomature, then the surgeon will spend an exceptional amount of time in theextraction of the crystalline lens. A cataract with age will becomeexceeding hard. MRI measurements have shown that the accommodativeciliary ring diameter constriction is reduced in elderly eyes ascompared to the younger eyes presented (Strenk, et al., Age-relatedchanges in human ciliary muscle and lens: a magnetic resonance imagingstudy. Invest Ophthalmology Vis. Sci. May 1999; 40(6): 1162-1169; Alsodiscussed in Glasser and Kaufman, Presbyopia: A View, The eMedicineJournal, Aug. 20, 2001, Volume 2, Number 8, pages 1-15). Elderly ciliarymuscles do not allow for as much accommodation. Dr. Glasser went on tosummarize work by Tamm (Tamm E, Croft M A, Jungkunz W, et al:Age-related loss of ciliary muscle mobility in the rhesus monkey. Roleof the choroid. Arch Ophthalmology June 1992; 110(6): 871-6; Tamm E,Lutjen-Drecoll E, Jungkunz W, et al: Posterior attachment of ciliarymuscle in young, accommodating old, presbyopic monkeys. InvestOphthalmology Vis Sci April 1991: 32(5): 1678-92; Tamm S, Tamm E, RohenJ W: Age-related changes of the human ciliary muscle. A quantitativemorphometric study. Mech Ageing Dev February 1992 62(2): 209-21)identifying several aspects that change with age. The total area of theciliary muscle decreases. Its length decreases almost by one half inadults aged 30-85 years, the areas of the longitudinal and reticularportions of the muscle decrease, the area of the circular portionincreases, the connective tissue in the muscle's longitudinal portionincreases, and the distance from the muscle's inner apex to the scleralspur decreases.

From Glasser's summary of Helmholtz we learned contraction of theciliary muscle releases the resting zonular tension on the equatorialedge of the lens; therefore, the ciliary diameter is less and thetension on the zonules is removed. Previously, from Glasser'sdiscussions in section three, under Mechanism of accommodation, welearned the ciliary body moves anteriorly, toward the iris, and theequatorial edge of the lens moves away from the sclera duringaccommodation. The zonular fibers become relaxed during accommodation.Dr. Glasser goes on to say the ciliary muscle, and ciliary processes arestretched during accommodation by the forward and axial movement of theapex of the ciliary muscle.

When intraocular lenses are implanted, the known intraocular lensesproduce a force on the haptics and many are vaulted or angled toward therear of the eye. Even three-piece whisker looking haptics exert forceagainst the equatorial area of the capsular sac. The current inventionis an intraocular lens with little or no force exerted by the anchoringportion. In certain embodiments, the lens 10 is positioned to biasagainst the zonules 42 and the posterior surface 32 of the iris 28, asbest seen in FIGS. 13A and 13B. In FIG. 13A, the anchoring portion 50 isrolled toward the anterior portion of the eye. In FIG. 13B, theanchoring portion 50 is rolled toward the posterior area of the eye. Inaddition to the anchoring portion 50 rolling in different directions, aspreviously mentioned, the lens 10 may be inserted either with the firstsurface 46 of the lens 10 facing the anterior chamber 26 of the eye, orthe second surface 44 of the lens 10 facing the anterior chamber 26 ofthe eye.

In other embodiments, the lens 10 is positioned to bias against theanterior surface 36 of the capsule 34 and the posterior surface 38 ofthe capsule 34, as seen in FIGS. 10, 11 and 12. In such embodiment, theintraocular lens 10 is placed in the capsule 34 with side forces fromthe posterior surface 38 and anterior surface 36 of the capsule 34pinching the haptics footplates 20, serving as the anchoring portion, tohold the less 10 in place. In addition to the anchoring portion 50,represented in the above-mentioned figures by the anchoring footplate20, rolling in different directions, as previously mentioned, the lens10 may be inserted either with the first surface 46 of the lens 10facing the anterior chamber 26 of the eye, or the second surface 44 ofthe lens 10 facing the anterior chamber 26 of the eye.

With the eye focused on far objects the ciliary body 40 is relaxed andthe zonules are tight, so the lens rest along the equator of thecapsular sac. As the eye looks at close objects the ciliary body 40swells, relaxing the zonules. The ciliary body 40 swelling displaces thevitreous body, which exerts a small force on the posterior capsule andzonules forcing them forward. Since the lens 10 has little or no forceexerted to keep the equatorial area of the capsular sac 34 stretched,the zonules 42 are free to move forward. As shown in FIG. 14, theforward movement, depicted by the axis of motion 37, of the zonules 42cause the capsular sac 34 containing the lens to move forward, which inturn moves the intraocular lens forward, which creates theaccommodation.

The invention disclosed herein provides surprising results with respectto correcting the problem of glare, halos, and rings of light. Theinvention also provides surprising results regarding the correction of alack of accommodation.

In certain embodiments, the haptic 18 areas can be sloped in theposterior direction, which causes the lens 10 to be positioned behindthe equator of the capsular sac 34 or in the direction of the retina.The anchoring portion 50 is also called a haptic 18, anchoring footplate20, plate haptic 22, or other similar structure. In other embodiments,the haptic 18 areas can also be sloped in the anterior direction, whichcauses the lens 10 to be position in front of the equator of thecapsular sac 34 or toward the iris 28. The haptic 18 areas can also beflat which leaves the lens 10 positioned along the equator of thecapsular sac 34. The haptic 18 area being of such a thickness to allowrolling, squeezing or other means of compressing of the optical portion48 and haptic 18 portion of the lens 10 for insertion into an incision.In certain embodiments, an incision is smaller than 1.5 mm. In otherembodiments, the incision is smaller than 2.5 mm. In other embodiments,the incision is about 1.5 mm. In certain embodiments, the opticalportion 48 of the lens 10 is constructed of a material different fromthe material used to construct the anchoring means 50, haptic 18, oranchoring footplate 20. In such an embodiment, the materials may befused, connected, or attached as commonly known within the art.

In certain embodiments, the anchoring portion 50 of the lens 10 is aplate haptic 22, as shown in FIG. 5. In other embodiments, the anchoringportion of the lens 10 is a plate haptic 22 with markers 24 whichindicate the direction or orientation of the lens 10, as shown in FIG.7.

The number of anchoring footplates 20, also called haptic footplates,can vary from none to eight. In certain embodiments having no anchoringfootplates 20, the lens 10 forms a dome design. In other embodiments, asbest seen in FIG. 5, the lens 10 can have a plate haptic 22.

As a means for comparison, the optic edge of a standard negative20-power lens has an edge thickness 0.360 millimeters when the opticdiameter is 4 millimeters. For the same power and optic diameter thecurrent invention has an edge thickness of 0.05 millimeters. Note thatfor the invention by Federov, et al., U.S. Pat. No. 5,258,025, to obtaina 20-diopter negative power lens with a 0.1 millimeter center thickness,the edge of the lens must be 0.348 millimeters. The edge thickness ofthe current invention with the same optical diameter, 4 millimeters, is0.0323 mm. However, the current invention has a maximum thickness for a20-diopter negative power lens of 0.0776 millimeters. As a consequenceof the thickness of the lens by Federov, et al., it is too thick to rollsince it will exceed the elastic limit of PMMA. Even if the lens byFederov, et al, were made from a material such as a hydrogel orhydrophilic acrylic, the lens would roll or squeeze, but the neededincision size will be significantly larger than the incision size forthe current invention.

U.S. Pat. No. 5,076,684, by Simpson, et al., describes a multi-focallens where there is no attempt to move the anterior and posteriorsurfaces close together in order to obtain a minimum thickness. Simpson,et al. describe annular rings, but not for the purpose of making thelens thinner. Simpson, et al. state in claim one that at least a portionof said optical power being produced by diffraction. In the 1800′sFresnel developed a diffractive lens having annular rings for use inlighthouses. The use of annular rings to develop multi-focal lens seemsto be the bases of the Simpson, et al. patent.

The current invention uses annular rings to create an extremely thinlens 10. In certain embodiments, the function of the annular rings 54 isto allow the lens 10 to be folded or rolled in order to fit through asmall incision. In other embodiments, the function of the annular rings54 is optical in nature as the presence of the annular rings 54 resultsin the reduction or elimination of glare, halos, and rings of light. Thepurpose of the intraocular lens 10 is to allow the material to be thinenough to roll without exceeding the elastic limit of the material andto reduce the incision size. None of the aforementioned prior artdiscusses using annular rings to obtain a lens thin enough to rollwithout exceeding the elastic limit of the material. In fact, none ofthe work referenced discusses making a lens thin enough to roll withoutexceeding the elastic limit of the material, nor do they discuss makingsuch a thin lens to reduce the incision size.

Thin lenses are desirable in order to remove the problem of glare andthe visualization of halos and rings of light. Since the firstintraocular lenses implantation patients complained of glare, halos andrings from intraocular lenses, it is considered a significant problem.Light catches on the edge and is reflected into the eye. The light isunfocused, but the thick edge reflects light that appears to the patientas a ring or halo. The condition is more noticeable at night when thepatient is in dimly lit places with high overhead lighting, such asstreetlights or tunnels. The condition exists to some extent even in themiddle of the day under bright sunlight. For the current inventiondescribed herein, the thin edge 16 of the optical portion 48 is fromabout 50 microns to about 200 microns thick. That is a very narrowthickness when compared to the standard six-millimeter optic lens, whichhas an optical portion edge of over 1000 microns for myopic lenses.

The present invention discloses a lens, and method of use thereof, thatis used to correct a lack of accommodation. By making the lens thin, andremoving material that is present in a thicker lens, the currentinvention allows for the anchoring means 50, such as an anchoringfootplate 20, or a plate haptic 22, to hold the lens in place and beflexible enough to allow axial movement of the lens 10. This axialmovement, as shown in FIG. 14, provides accommodation for the patient.Previous designs, such as U.S. Pat. No. 6,197,059, by Cumming, used ahinge concept to allow for movement of the lens. In the currentinvention the thin design allows the optical portion 48 of the lens 10to be light enough and the anchoring means 50, such as an anchoringfootplate 20, or a plate haptic 22, to be flexible enough for the lens10 to move with the natural movement of the capsule. Natural movementcan come from the removal of tension on the zonules, which allow them toaxially move forward, creating natural forward motion.

As shown in FIGS. 16A, 16B, and 16C, prior to implantation, the lens 10is rolled to allow for insertion in the incision. The lens 10 may berolled around an object, such as a rod 43, as shown in FIG. 16A. Inother embodiments, the lens 10 may be merely rolled upon itself.

The lens 10 is warmed, or heated, prior to rolling or deforming. Incertain embodiments, the lens 10 is warmed to around 100 degrees F. Inother embodiments, the lens 10 is warmed to a temperature from about 90degrees F. to about 150 degrees F. When the lens is cooled to about roomtemperature, or dehydrates, the lens becomes brittle. In certainembodiments, the temperature of the lens 10 reduced prior to insertingthe lens 10 into an incision of the eye. When the lens 10 isre-hydrated, or warmed, as it will be by the fluid present in the eye,the lens 10 will unroll by itself.

In certain embodiments, an incision is cut in the eye so that the lens10 may be placed therein. Common protocols are well known in the artregarding the instruments for cutting and the location of such incision.In certain embodiments, the incision is less than 1.5 millimeters. Inother embodiments, the incision is less than 2.5 millimeters. As shownin FIG. 16B, the lens is inserted through the incision into the eye 15.FIG. 16C shows the lens 10 inserted into the eye 15 and starting tounroll, or deform.

As shown in FIG. 11, in certain embodiments, the lens 10 may be placedin the capsule 34, being biased against the anterior surface 36 of thecapsule 34 and the posterior surface 38 of the capsule 34. Also, asshown in FIG. 11, the anchoring portion of the lens may curl toward theanterior direction of the eye. As shown in FIG. 12, the anchoringportion may curl toward the posterior direction of the eye. In otherembodiments, the direction of the lens 10 may be reversed. Also, lenseshaving other concavities and convexities of the first optical surfaceand the second optical surface may be used as shown in theabove-mentioned figures.

In another embodiment, as shown in FIGS. 13A and 13B, the anchoringportion 50 is biased against the zonules 42 and the posterior surface 32of the iris 28. As mentioned above, the anchoring portion 50 of the lens10 may curl in the anterior direction, as in FIG. 13A, or in theposterior direction, as in FIG. 13B. In other embodiments, the directionof the lens 10 may be reversed so that the posterior facing surface, asshown in either FIG. 13A or 13B is anterior facing. Also, lenses havingother concavities and convexities of the first optical surface and thesecond optical surface may be used as shown in the above-mentionedfigures. Also, the anchoring portion may accordion. Accordion of theanchoring portion 50, in this embodiment an anchoring footplate 20, isdepicted in FIG. 10.

In certain embodiments, subsequent to insertion, as the lens 10 unrollsinside the natural lens sac 34 and the lens 10 opens until the anchoringfootplates 20, also called haptic footplates, strike tissue. When theanchoring footplates 20 strike tissue, then the lens stops unfolding.The ultra-thin haptic 18 and anchoring footplate 20 exert very littleforce on the inside of the natural lens sac 34 that originally held thenatural lens of the eye. Subsequent to insertion and unrolling of thelens 10, the incision will most likely require no repair, which is wellknown in the art.

The lens 10 is capable of moving within the natural lens sac 34. Whenthe anterior portion of the ciliary body 40 swells the force on theanterior zonules is reduced. The pressure in the eye then forces thelens 10 forward allowing axial movement. The thin optical portion 48 andthin haptic 18 allow the lens 10 to move axially providingaccommodation. In other embodiments, the method of correction a loss ofaccommodation further comprises curling the haptic footplate 20 towardan anterior surface 36 of the natural lens sac 34, as shown in FIG. 11.In other embodiments, the method of correction a loss of accommodationfurther comprises curling the haptic footplate 20 toward a posteriorsurface 38 of the natural lens sac 34, as shown in FIG. 12. In otherembodiments, the lens 10 is inserted in a ciliary body 40 of an aphakiceye. In still other embodiments, the lens 10 is inserted and attaches tothe posterior surface of the iris 32. When the ciliary muscles relax thelens does not stretch the sack and moves forward. In certainembodiments, the lens 10 is capable of moving within the anteriorchamber 26 of the eye. This action creates accommodation for thepatient.

The artificial lens is typically manufactured from an acrylic plastic,which can be polymethylmethacrylate (PMMA), or a hydrophobic acrylicwith a lower modulus of elasticity allowing the material to roll or bendwithout permanent deformation. Another acceptable acrylic material is ahydrophilic material, such as a copolymer of hydroxy ethyl ester ofmethacrylate acid and methyl methacrylate, hydrogel, which has a veryhigh modulus of elasticity and is brittle and glassy when dry butbecomes soft and plastic on swelling with water (Plastics TechnologyHandbook, Third Edition, Manas Chanda and Salil K. Roy, Marcel Dekker,Inc., New York, page 584). Such material is a preferred material becauseit is biologically compatible with the tissue of the eye, and it doesnot degrade over time.

The material of manufacture of the lens can be any biocompatible,optically suitable, flexible, and machinable or moldable material withan index of refraction between 1.4 and 2.0. Examples of materials thatmay be used to manufacture the lens include, but are not limited to,acrylic, hydrophilic acrylic, hydrophobic acrylic, orpolymethylmethacrylate (PMMA), Hydrophilic materials with water contentsfrom over 75 percent to 18 percent water used for the manufacture of thecurrent invention can be purchased from Contamac Ltd, BearwaldenBusiness Park, Saffron Walden Essex, CB11 4JX, United Kingdom. Onematerial is a Poly hydroxy ethyl methacrylate with water content of 38%.A second material is a copolymer of N-vinyl pyrrolidone and2-hedroxyehtyel methacrylate. Similar materials have water contents ashigh as 76%. Forms of contact lens materials using a copolymer of alkylmethacrylate with siloxanyl methacrylates and fluorine containingcomonomer as also available from the same supplier. For intraocularlenses Contamac produces copolymer of hydroxy ethyl methacrylate andmethyl methacrylate with a UV blocker. The water content can vary from18.5% to 26%. The same company also manufactures PMMA buttons. Othersuppliers also manufacture silicone compounds for the molding of lenses.

In certain embodiments, the optical portion 48 is constructed ofacrylic, hydrophilic acrylic, hydrophobic acrylic, or hydrogel. In otherembodiments, the optical portion is constructed of acrylic and theanchoring portion is constructed of polymethylmethacrylate. In stillother embodiments, the optical portion is constructed of hydrogel andthe anchoring portion is constructed of polymethylmethacrylate. In otherembodiments, the optical portion is constructed of hydrogel and theanchoring portion is constructed of acrylic.

Experience from cataract surgeries shows that the astigmatism will bereduced if a smaller incision is made. It follows that if the lens couldbe manipulated through a smaller incision, it will reduce the severityof the astigmatism. The optical portion of the intraocular lens, though,must have a diameter of at least approximately 6 mm in order to properlycover the pupil. So, the only way to pass a lens through a smallerincision is to first fold the lens into a U-shape or roll it so that theopposite edges are overlapping. However, currently designed hydrophobicor hydrophilic lenses are either rigid and too brittle to be rolled orfolded or when folded still require an incision size of approximatelythree millimeters, which still produces astigmatism. While it is knownthat a material which is rigid at a given thickness may be flexible at alesser thickness, the maximum material thickness under which PMMA isflexible is approximately 0.25 mm. Other acrylic materials have muchbetter flexibility but still require an incision size large enough tocreate astigmatism.

A lens has a convex first surface into which incident light passes. Thelens also has a second surface 44, opposite the first surface, fromwhich the refracted light exits. The second surface 44 may be convex,planar or concave. The power of the lens is determined by the curvatureof the first surface 46 and second surface 44.

As shown in FIG. 2, to prevent glare, halos, and rings of light seen bythe patient the edge 16 of the optical portion 48 of the lens 10 isextremely thin. In the preferred embodiment the lens edge 16 is 200microns. To prevent flexing of the optical portion 48, the haptics 18are thinner than the edge 16. In certain embodiments, the hapticfootplate 20 thickness is approximately 50 microns. In otherembodiments, the haptic footplate 20 thickness is less than 50 microns.In still other embodiments, the haptic footplate 20 thickness is fromabout 50 microns to about 200 microns. As described herein, theanchoring portion 50 may be a haptic footplate 20, plate haptic 22, orother type of haptic. The anchoring portion 50 has a thickness of about10 microns to about 100 microns. In other embodiments, the anchoringportion 50 has a thickness of less than 100 microns. The haptics 18 canhave multiple haptic footplates 20 from two to eight. The preferredembodiment has four haptic footplates 20 as shown in FIG. 7. In thepreferred embodiment the haptic footplates 20 roll toward the anteriorchamber 26 of the eye, as shown in FIG. 11.

Once a surgeon centers the lens 10 in the eye, then the haptic forcewill hold the lens centered. The thin construction of the haptic 18places virtually no radially inward pressure on the internal surfaces ofthe eye.

The exact diameter of a lens 10 is determined by several factors. When alens 10 is inserted in the natural lens sac 34, also known as thecapsular sac, in the posterior location, the lens 10 diameter is suchthat it fits in the capsular sac 34 where the natural lens has beenremoved. Alternatively, the lens 10 can be placed in the ciliary cavity45, located between the posterior surface of the iris 32 and the zonularstructure 42, also known as ligaments, of the eye. When the lens 10 isplaced in the capsular sac 34, the lens 10 diameter will be from about10 millimeters to about 14 millimeters with the preferred embodiment tobe approximately 11 millimeters. As shown in FIG. 1, the lens 10diameter is from about 10 mm to about 14 mm. The plate style lens has anangle 94, shown in FIGS. 6 and 8, that can vary from +10° to 0° with thepreferred embodiment posterior chamber lens of zero degrees.

In one embodiment, the lens 10 is implanted into the human eye through a1.5 millimeter incision in the cornea 96 or sclera 98. The steps ofrolling the lens 10, inserting the lens 10 in the eye 15, and theinitial unrolling of the lens 10 are shown in FIG. 16. Such embodimentuses the ultra thin haptic 18 with the optical portion 48, as shown ineither FIG. 2 or 3. During the implantation of this specific embodiment,or any of the other embodiments previously mentioned that describeimplantation, the eye is irrigated with a Balanced Salt Solution, BSS,manufactured by one of several pharmaceutical suppliers and labeled assuch which are well know to persons with know in the art. In certainembodiments, implantation occurs at around room temperature and the lensunrolls when the intraocular fluid elevates its temperature to a rangeof about 85° F. to 100° F., with the preferred temperature to be 98.6°F. FIG. 16 depicts the steps of rolling the lens, inserting the rolledlens through the incision, and the initial unrolling of the lens in theeye.

There are many techniques used to enter the eye in order to remove thecataract. The size and location of the incision can affect the curvatureof the cornea 96 and potentially induce astigmatism. Having a smallerincision can minimize this. Incisions in the sclera 98 (the white partof the eye) are typically 6 mm in length, whereas incisions in the clearpart of the cornea 96 can be considerably smaller (around 3 mm). Thesecorneal incisions are so small, that they usually do not even requiresutures to close the wound. Furthermore, unlike cutting in the sclera98, there is no bleeding associated with making an incision in thecornea 96. The present invention reduces the corneal incision to assmall as 1.5 millimeters or less. Many surgeons do what is calledbi-manual techniques by inserting two incisions of 1.5 millimeters andremoving the cataract through one incision with a phaco emulsificationmachine. The phaco emulsification machine is similar to an ultra smalljackhammer that fits inside a one-millimeter cannula. The secondincision is used to insert an instrument for manipulation of thecataractous natural lens. The instrument inserted in the second incisionalso has an opening to supply a balanced salt solution to the eye. Asthe cataractous natural lens is being chopped into small fragments, itis carried away by suction. The BSS replaces the lost fluid in the eye.Today most modern cataract surgeons use a phaco emulsification systemthat requires a 2.5 millimeter or small incision. To implant a standardcataract lens, the incision size has to be enlarged.

In one embodiment, the method of correcting or improving either a lossof accommodation or lack of accommodation comprises making an incisionfor access to the anterior chamber of an eye having a length less than1.5 mm; providing a lens disclosed herein, having a diameter disclosedherein; integrally providing support haptics for anchoring the lens;rolling the lens and the support haptics without exceeding the elasticlimit of the material into a rolled package; inserting the rolledpackage into the anterior chamber of the eye via the incision; unrollingthe rolled package internally of the anterior chamber; anchoring thehaptics as disclosed herein; and repairing the incision, if necessary,made in the eye.

In other embodiments, the method of correcting or improving either aloss of accommodation or lack of accommodation comprises making anincision for access having a length of less than 1.5 mm; providing alens formed of an optical grade of an acrylic plastic material having athickness no greater than 0.25 mm, having a diameter of 11 mm, the lenshaving a convex first surface and a second surface, wherein the secondsurface comprises a central disk which is radially surrounded by aseries of annular rings found on the central disk in said series ofannular rings forming a series of radial steps along said secondsurface; integrally providing an anchor for the lens support haptics foranchoring the lens; rolling the lens and the support haptics withoutexceeding the elastic limit of the material into a rolled package;inserting the rolled package into the eye via the incision; unrollingthe rolled package; and anchoring the haptics.

As described above, the series of annular rings 14 in the opticalportion 48 of the lens 10 perform several functions. The series ofannular rings 14 reduce the thickness of the lens 10 thereby reducingthe weight of the lens 10. The reduced weight of the optic allows theanchoring means, including, but not limited to, the haptic 18, the platehaptic 22, and/or the anchoring footplate 20, to be thinner and stillhave the rigidity to correctly position the lens 10 in the eye.Additionally, thin haptics 18, including plate haptics 22, allows thelens 10 to move forward on swell tension of the ciliary body 40producing accommodation, as shown in FIG. 14.

One surface of the lens 10 is a continuous curve and spherical. Anydeviation from the paraxial-ray formulas of the Gauss (Fundamentals ofOptics, Jenkins and White, page 149) theory to give an accurate accountof image detail is known as spherical aberration. Since a spherical lensproduces aberration, many commercial computer programmed lathes cut in aspherical pattern, and the Gaussan formulas are based on sphericallenses, light rays entering the spherical lens focus at a shorter focallength as the distance from the center of the lens increases. Thiseffect is known as spherical aberration and causes glare in the lensesfrom unfocused light. The series of annular rings 14 are designed tocorrect for spherical aberration from the continuous curve by adjustingthe focal length from each ring 54 to focus at the same point as theprime meridian of the lens. The prime meridian of the lens is the focallength of the lens along the central axis of the lens. Along with thecorrection for spherical aberration, the lens 10 disclosed hereincorrects for coma, which is the second of the monochromatic aberrationsof third-order theory. As stated in Fundamentals of Optics, Jenkins andWhite page 162 and 163, “[i]t derives its name from the comet likeappearance of the image of an object point located just off the lensaxis.” Additionally, the authors state that “[i]t appears themagnification is different in different parts of the lens”.

The lens design further claims an extremely thin lens where all theexcess materials for the optical portion 48, haptic 18, and anchoringfootplates 20 have been removed so that the lens 10 is extremelylightweight and should not cause undue force against the eye. Again, thethinness of the lens 10 reduces the mass of the lens 10 thus allowing itto be folded, rolled or squeezed in order to pass through an incision inthe eye of less than 1.5 millimeters.

This present invention may be practiced by modifying the lens disclosedby Worst, in U.S. Pat. Nos. 5,192,319 and 4,215,440. For example, theoptical portions of the Worst lens may be modified with the opticalsurfaces of the present invention.

In other embodiments, the optical portion 48 of the lens 10 has a convexfirst surface 46. The periphery of the optical portion 48 comprises aparallel lenticular area. The parallel lenticular area is of uniformthickness and is for preventing the phenomenon known as edge effects. Anon-optical transition area 52, as shown in FIG. 5, surrounds theparallel lenticular area. In other embodiments, the anchoring portion 50extends from the transition area 52. In still other embodiments, theanchoring portion 50 comprises a pair of haptics 18 circumvolving theoptical portion 48 of the lens 10. Each of the pair of haptics 18 has anouter circumferential haptic edge for biasing against the tissue of theeye.

The central disk 12 and series of annular rings 14 form a series ofradial steps across the second surface 44 to maintain a close proximityto the first surface 46. The thickness of the central disk 12 at theapex of the first surface 46 is less than or equal to a predeterminedmaximum thickness so that the lens 10 may be rolled without exceedingthe elastic limit of the lens material. The thickness of the peripheryof the central disk 12 is greater than or equal to a predeterminedminimum thickness so that the lens 10 will retain its pre-flexed shapesubsequent to being rolled.

In certain embodiments, the surfaces of the central disk 12 and each ofthe annular rings 54 are convex. The thickness of the central disk 12 atthe apex of the first surface 46 is less than or equal to thepredetermined maximum thickness. The thickness of the periphery of thecentral disk 12 is greater than or equal to a predetermined minimumthickness.

In other embodiments, the surfaces of the central disk 12 and each ofthe annular rings 54 are concave. The thickness of the central disk 12at the periphery of the central disk 12 is less than or equal to thepredetermined maximum thickness. The thickness of the lens between theapex of the first surface 46 and the central disk 12 is greater than orequal to a predetermined minimum thickness.

All patents and publications disclosed above are expressly incorporatedherein by reference in their entirety.

This invention thus being described, it will be obvious that the samemay be varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the present invention, and allsuch modifications as would be obvious to one of ordinary skill in theart are intended to be included within the scope of this invention.

Thus, although there have been described particular embodiments of thepresent invention of a new and useful Small Incision Lens and Method ofUse Thereof, it is not intended that such references be construed aslimitations upon the scope of this invention except as set forth in thefollowing claims.

What is claimed is:
 1. An intraocular Lens, comprising: an opticalportion having a first optical surface, wherein the optical portion isconstructed of a material which is biologically compatible with a tissueof an eye, the optical portion having a predetermined maximum thicknessunder which the material may be rolled without exceeding the elasticlimit of the material, said optical portion having a predeterminedminimum thickness above which the material retains a normal shape,wherein the intraocular lens is capable of deforming for passage throughan incision having a length smaller than about 1.5 millimeters so thatthe intraocular lens is placed into the eye; the optical portion havinga second optical surface, wherein the second optical surface comprises acentral disk which is radially surrounded by a series of annular rings,the central disk and the series of annular rings forming a series ofradial steps along the second optical surface so that a focal lengthfrom an annular ring is adjusted to focus at a same point as a primemeridian of the lens, wherein the second optical surface and the firstoptical surface have a minimum separation of 0.025 mm and a maximumseparation of 0.45 mm; and an anchoring portion attached to the opticalportion, wherein the anchoring portion is constructed of a material,which is biologically compatible with a tissue of an eye, wherein theanchoring portion is capable of biasing against a support structure ofthe eye.
 2. The lens of claim 1, wherein the second optical surface andthe first optical surface have a minimum separation of 0.025 mm and amaximum separation of 0.065 mm.
 3. The lens of claim 1, wherein thefirst optical surface and the second optical surface are of apredetermined convexity for obtaining a particular focusing power. 4.The lens of claim 1, wherein the first optical surface and the secondoptical surface are of a predetermined concavity for obtaining aparticular focusing power.
 5. The lens of claim 1, wherein the firstoptical surface is of a predetermined convexity for obtaining aparticular focusing power, and wherein the second optical surface is ofa predetermined concavity for obtaining a particular focusing power. 6.The lens of claim 1, wherein the first optical surface is of apredetermined concavity for obtaining a particular focusing power, andwherein the second optical surface is of a predetermined convexity forobtaining a particular focusing power.
 7. The lens of claim 1, whereinthe anchoring portion has a thickness of about 10 microns to about 100microns.
 8. The lens of claim 7, wherein the anchoring portion furthercomprises a plurality of anchoring footplates.
 9. The lens of claim 7,wherein the anchoring portion further comprises a plate haptic.
 10. Thelens of claim 1, wherein the optical portion is constructed of amaterial having an index of refraction from about 1.4 to about 2.0. 11.An intraocular lens, comprising: an optical portion having a firstoptical surface, wherein the first optical surface is of a predeterminedconvexity for obtaining a particular focusing power, wherein the opticalportion is constructed of a material which is biologically compatiblewith a tissue of an eye, the optical portion having a predeterminedmaximum thickness under which the material may be rolled withoutexceeding the elastic limit of the material, said optical portion havinga predetermined minimum thickness above which the material retains anormal shape, wherein the intraocular lens is capable of deforming forpassage through an incision having a length smaller than about 1.5millimeters so that the intraocular lens is placed into the eye; theoptical portion having a second optical surface, wherein the secondoptical surface comprises a central disk which is radially surrounded bya series of annular rings, the central disk and the series of annularrings forming a series of radial steps along the second optical surfaceso that a focal length from an annular ring is adjusted to focus at asame point as a prime meridian of the lens, each annular ring having anouter surface, wherein the central disk is of a predetermined convexityfor obtaining a particular focusing power, wherein the second opticalsurface and the first optical surface have a minimum separation of 0.025mm and a maximum separation of 0.065 mm; and an anchoring portion havinga thickness of about 10 microns to about 100 microns attached to theoptical portion, wherein the anchoring portion is constructed of amaterial which is biologically compatible with a tissue of an eye,wherein the anchoring portion is capable of biasing against a supportstructure of the eye.
 12. The lens of claim 11, wherein the intraocularlens is constructed of an acrylic material.
 13. The lens of claim 11,wherein the intraocular lens is constructed of a hydrophilic acrylicmaterial.
 14. The lens of claim 11, wherein the intraocular lens isconstructed of a hydrophobic acrylic material.
 15. The lens of claim 11,wherein the intraocular lens is constructed of a polymethylmethacrylatematerial.
 16. The lens of claim 11, wherein the intraocular lens isconstructed of a hydrogel material.
 17. The lens of claim 11, whereinthe optical portion is constructed of a material selected from the groupconsisting of acrylic, hydrophilic acrylic, hydrophobic acrylic, andhydrogel.
 18. The lens of claim 11, wherein the optical portion isconstructed of an acrylic material and the anchoring portion isconstructed of a polymethylmethacrylate material.
 19. The lens of claim11, wherein the optical portion is constructed of a hydrogel materialand the anchoring portion is constructed of a polymethylmethacrylatematerial.
 20. The lens of claim 11, wherein the optical portion isconstructed of a hydrogel material and the anchoring portion isconstructed of an acrylic material.
 21. The lens of claim 11, whereinthe outer surface of each annular ring is of a predetermined concavityso that a focal length from the annular ring is adjusted to focus at asame point as a prime meridian of the lens.
 22. The lens of claim 11,wherein the outer surface of each annular ring is of a predeterminedconvexity so that a focal length from the annular ring is adjusted tofocus at a same point as a prime meridian of the lens.
 23. The lens ofclaim 11, wherein the anchoring portion further comprises a directionalmarker.
 24. An intraocular lens, comprising: an optical portion having afirst optical surface, wherein the optical portion is constructed of amaterial which is biologically compatible with a tissue of an eye,wherein the optical portion is constructed of a material having an indexof refraction from about 1.4 to about 2.0, wherein the first opticalsurface is of a predetermined concavity for obtaining a particularfocusing power, the optical portion having a predetermined maximumthickness under which the material may be rolled without exceeding theelastic limit of the material, said optical portion having apredetermined minimum thickness above which the material retains anormal shape, wherein the intraocular lens is capable of deforming forpassage through an incision having a length smaller than about 1.5millimeters so that the intraocular lens is placed into the eye; theoptical portion having a second optical surface, wherein the secondoptical surface comprises a central disk which is radially surrounded bya series of annular rings, the central disk and the series of annularrings forming a series of radial steps along the second optical surfaceso that a focal length from an annular ring is adjusted to focus at asame point as a prime meridian of the lens, each annular ring having anouter surface, wherein the second optical surface and the first opticalsurface have a minimum separation of 0.025 mm and a maximum separationof 0.065 mm; and an anchoring portion having a maximum thickness of 100microns attached to the optical portion, wherein the anchoring portionis constructed of a material which is biologically compatible with atissue of an eye, wherein the anchoring portion is capable of biasingagainst a support structure of the eye.
 25. The lens of claim 24,wherein the central disk has a predetermined convexity so that afocusing power is obtained and the series of annular rings have apredetermined convexity.
 26. The lens of claim 24, wherein the centraldisk has a predetermined concavity so that a focusing power is obtainedand the series of annular rings have a predetermined concavity.
 27. Thelens of claim 24, wherein the anchoring portion is capable of biasingagainst an anterior surface of a capsule and a posterior surface of thecapsule, wherein biasing produces a minimum radial force on the eye. 28.The lens of claim 24, wherein the anchoring portion is capable ofbiasing against a zonula and a posterior surface of an iris, whereinbiasing produces a minimum radial force on the eye.
 29. The lens ofclaim 28, wherein the anchoring portion is curled so that the anchoringportion is pinched between the zonula and the posterior surface of theiris.
 30. The lens of claim 27, wherein the anchoring portion is curledso that the anchoring portion is pinched between the anterior surface ofthe capsule and the posterior surface of the capsule.
 31. The lens ofclaim 23, wherein the directional marker further comprises an opening.32. The lens of claim 31, wherein the anchoring portion is arched sothat the anchoring portion wedges between the support structures of theeye.
 33. The lens of claim 11, wherein the anchoring portion is curvedso that the anchoring portion biases between support structures of theeye.
 34. The lens of claim 7, wherein the anchoring portion is curved sothat the anchoring portion provides and exerts a force against supportstructures of the eye.